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Systemic Anti-Cancer Therapy Regimen Library

GU PROS Castration sensitive Metastatic - DOCEtaxel Q3W and darolutamide

Treatment Overview

Usually up to 6 cycles of DOCEtaxel in combination with darolutamide.

Continue darolutamide until disease progression or unacceptable toxicity.

Cycles 1 to 6 - 21 days - DOCEtaxel and darolutamide

Cycle length:
21

Some centres may wish to replace the three oral doses of dexamethasone 8 mg premedication with a single intravenous dose of dexamethasone 20 mg prior to DOCEtaxel infusion.

Cycle 7 (and all further cycles) - 28 days - darolutamide continuation

Cycle length:
28

Cycle details

Cycles 1 to 6 - 21 days - DOCEtaxel and darolutamide

Medication Dose Route Days Max Duration
dexamethasone * 8 mg Twice daily oral administration 0, 1, 2
DOCEtaxel * 75 mg/m² intravenous 1 60 minutes
darolutamide 600 mg Twice daily oral administration 1 to 21
domperidone 10 mg Three times daily oral administration 1
loperamide 2 mg oral administration 1

Some centres may wish to replace the three oral doses of dexamethasone 8 mg premedication with a single intravenous dose of dexamethasone 20 mg prior to DOCEtaxel infusion.

Cycle 7 (and all further cycles) - 28 days - darolutamide continuation

Medication Dose Route Days Max Duration
darolutamide 600 mg Twice daily oral administration 1 to 28

Full details

Cycles 1 to 6 - 21 days - DOCEtaxel and darolutamide

Day: 0

Medication Dose Route Max duration Details
dexamethasone * 8 mg Twice daily oral administration
Instructions:

Take with food. 

Day: 1

Medication Dose Route Max duration Details
dexamethasone * 8 mg Twice daily oral administration
Instructions:

Take with food. 

DOCEtaxel * 75 mg/m² intravenous 60 minutes
Instructions:
  • Prepare solution in PVC-free bag and administer via polyethylene lined administration set.
  • Please carry out graded challenge as per institutional policy.
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

domperidone 10 mg Three times daily oral administration
Instructions:

When required for nausea and/or vomiting.

  • The choice of rescue antiemetic may be substituted to reflect institutional policy or individual patient characteristics.
loperamide 2 mg oral administration
Instructions:
Take TWO capsules (=4 mg) at onset of loose bowel motions and a further ONE capsule (=2 mg) for every loose bowel motion (maximum of EIGHT capsules in 24 hours), or use as directed by oncologist or haematologist.

Day: 2

Medication Dose Route Max duration Details
dexamethasone * 8 mg Twice daily oral administration
Instructions:

Take with food. 

darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 3

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 4

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 5

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 6

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 7

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 8

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 9

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 10

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 11

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 12

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 13

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 14

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 15

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 16

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 17

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 18

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 19

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 20

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 21

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Cycle 7 (and all further cycles) - 28 days - darolutamide continuation

Day: 1

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 2

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 3

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 4

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 5

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 6

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 7

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 8

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 9

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 10

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 11

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 12

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 13

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 14

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 15

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 16

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 17

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 18

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 19

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 20

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 21

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 22

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 23

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 24

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 25

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 26

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 27

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Day: 28

Medication Dose Route Max duration Details
darolutamide 600 mg Twice daily oral administration
Instructions:

Take with food. Swallow whole, do not crush or chew.

Supportive Care Factors

Factor Value
Diarrhoea risk: Variable
Emetogenicity: Variable
Hypersensitivity / Infusion related reaction risk: Variable

Diarrhoea risk: Anti-diarrhoeals are usually prescribed with this treatment cycles 1-6 (DOCEtaxel).


Emetogenicity:

  • LOW cycles 1-6 (DOCEtaxel).
  • MINIMAL to LOW (darolutamide alone): Antiemetics may be required with continuous dosing of oral anti-cancer medicines with MINIMAL to LOW emetic risk; an individualised approach is appropriate.

Hypersensitivity / Infusion related reaction risk: HIGH cycles 1-6 (DOCEtaxel). 

References

Smith MR, Hussain M, Saad F, et al.; ARASENS Trial Investigators. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. N Engl J Med. 2022 Mar 24;386(12):1132-1142., PMID: 35179323

Hussain M, Tombal B, Saad F, et al. Darolutamide Plus Androgen-Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer by Disease Volume and Risk Subgroups in the Phase III ARASENS Trial. J Clin Oncol. 2023 Jul 10;41(20):3595-3607., PMID: 36795843

Pfizer New Zealand Limited. DBL Docetaxel New Zealand Data Sheet 07 August 2020. https://www.medsafe.govt.nz/profs/Datasheet/d/dbldocetaxelinj.pdf (Accessed 26 November 2020)

Bayer New Zealand Limited. Nubeqa (darolutamide) New Zealand Data Sheet 6 August 2024. https://www.medsafe.govt.nz/Profs/Datasheet/n/nubeqatab.pdf (Accessed 14 January 2025).

* The medicines, doses, combinations, and schedule in this treatment regimen have been carefully reviewed against international best practice guidelines by specialists in medical oncology around New Zealand and this advice has been accepted for publication by Te Aho o Te Kahu (the Cancer Control Agency). Sometimes medicines that are used in routine clinical practice have not been through a formal review process by the NZ Medicines Regulator Medsafe and are therefore considered unapproved or off-label. These medicines are legally able to be prescribed through sections 25 and 29 of the Medicines Act and by obtaining informed consent from patients. All treatment regimens listed on this website have been through robust peer review and are considered an accepted standard of care, whether prescribed through sections 25 or 29 or carrying formal Medsafe Approval.

s29: This symbol indicates that some formulations of the associated medicine are legally only able to be prescribed under section 29 of the Medicines Act. You can see which formulations are section 29 by hovering over the s29 symbol. You can access full medication details from the New Zealand Formulary by clicking on the medication name. Each clinician retains full responsibility for ensuring they have complied with all relevant obligations and requirements of section 29 including obtaining informed patient consent prior to prescribing the applicable medicine.